Close up of a mosquito sucking blood on human skin. This mosquito is a carrier of Malaria, Encephalitis, Dengue and Zika virus.

Responsibly Developing Gene Drives: The GeneConvene Global Collaborative

By James Toomey

Researchers believe that gene drives could eliminate vector-borne diseases such as malaria, by modifying mosquito species or eradicating those that carry disease, kill off invasive species, and combat the growing problem of pesticide resistance.

A gene drive is a technique for genetically modifying entire species of wild organisms. Genetically modified individuals of the species are released into the wild, so as to raise the probability that a particular gene will be passed onto the species’ progeny via reproduction.

Over the course of many generations, the gene — even if detrimental — can spread to an entire population.

But as of now, this is all hypothetical. No gene drive has been tested in the wild, and many people are skeptical that they should ever be used.

The GeneConvene Global Collaborative, a project of the Foundation for the National Institutes of Health, was started this past July to promote the responsible development and regulation of gene drive technologies. It brings together researchers, regulators and stakeholders around the world to develop best practices for gene drive research and implementation.

Because of my prior writing on this topic, I participated in GeneConvene’s fall webinar series and spoke with scientists there about the project.

Debates about the regulation of gene drives are unique in several respects, because the technology is unique in several respects.

For one thing, gene drives have few, if any, obvious commercial applications. The proposed uses involve essentially one-off projects, funded by governments or foundations, to advance public health or ecological goals, such as the elimination of malaria or an invasive species. This characteristic appears to have splintered the environmentalist opposition to genetically modified organisms, revealing latent disagreement between environmentalists opposed to traditional GMOs because of their opposition to commercial agriculture (or out of a consequentialist concern for the environment) and those more deontologically opposed to human intervention in the natural order. Indeed, several more moderate environmentalist groups have suggested support for some uses of gene drives, while ideological ones remain opposed.

Moreover, gene drives interact with geopolitical considerations in interesting ways. On the one hand, gene drive use is necessarily geographically limited in that most currently proposed applications would only be useful in certain areas of the world — Africa and other places where mosquito-borne illnesses are endemic, and islands in which invidious invasive species have established themselves.

This means that deep engagement between Western researchers developing and funding these technologies and scientists, governments, and populations in the developing world is necessary to ethically bring these projects to fruition. On the other hand, because they are designed to fundamentally alter a wild species, gene drives cannot plausibly be contained within national borders. This means that domestic regulators and regional governance bodies will have to work together to avoid international disagreement.

Finally, public health interventions involving gene drives are situated in an ambiguous regulatory locus between environmental and health regulators. Because they necessarily involve genetically modified organisms, and their potential risks are essentially environmental, most countries would regulate gene drive technologies through their government’s environmental regulator.

But novel scientific interventions designed to eradicate diseases are generally thought of as health interventions — and the benefits of a gene drive could be comparable to that of a vaccine — so health regulators also plausibly have an interest in ensuring that gene drives will be safe and effective before they are deployed.

Indeed, the phrases “safety and efficacy,” and “informed consent,” the language of health regulators, appear commonly in discussions about gene drive development. In the short run, researchers will have to engage with interested stakeholders at many levels of government to conduct field trials. In the long run, theorizing about where interventions like gene drives fit into administrative structures will be necessary to develop a permanent regulatory solution.

None of these challenges, however, are insurmountable. The British company Oxitec recently has been approved to release genetically modified mosquitos designed to produce non-viable female offspring — not a gene drive, but a similar idea — in Florida and Texas after releasing millions of the GM mosquitos in Brazil and the Caymans. And the World Health Organization recently released a position statement supporting continued research into the use of gene drives for control of vector-borne diseases.

However, the media’s skepticism of gene drives is palpable (ubiquitously referring to gene drives as “controversial,” with such titles as “We Can Alter Entire Species, but Should We?” and such opening lines as “A plan to release . . . genetically modified mosquitoes into the Florida Keys . . . received final approval from local authorities, against the objection of many local residents and a coalition of environmental advocacy groups”; which I have written about before).

GeneConvene’s mission is to bring together these interested stakeholders and develop a path towards the responsible development of gene drives as they become technically feasible. It is an honorable one. The elimination of malaria is one of the great, achievable goals of our lifetime, and gene drives may well be the best way to get there. GeneConvene has done a great deal of work on these issues already, and anyone interested should check out their website. But they’ve reported some challenges in reaching some stakeholder groups, especially the ecology community and stakeholders in Africa. If any readers have any contacts in those groups, GeneConvene would appreciate hearing from you.

James Toomey

James Toomey is an Assistant Professor of Law at the Elisabeth Haub School of Law at Pace University. Prior to joining the faculty at Pace, James was a Climenko Fellow & Lecturer on Law at Harvard Law School. His scholarly work has appeared in the Virginia Law Review, the North Carolina Law Review, the Harvard Journal on Legislation and more.

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